A Multi-center, Single-arm, Open, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety … (NCT03789617) | Clinical Trial Compass
UnknownPhase 1/2
A Multi-center, Single-arm, Open, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of EBViNT Cell (EBV Specific Autologous CD8+ T Cell) in Patients With Treatment Failed Epstein Barr Virus (EBV)-Positive Malignancies
South Korea72 participantsStarted 2018-12-14
Plain-language summary
The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV) positive malignancies The present study investigates with 5 parts; Part1-phase I: IP single therapy on ENKL and solid tumors Part2-phase I: IP + lymphodepletion on solid tumors Part 3\&5- Phase IIa: IP single therapy on each ENKL and solid tumors Part 4- Phase IIa: IP + lymphodepletion on solid tumors
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 19 years of age
. Patients with lymphomas or solid tumors who have been found to be positive for EBV encoded RNA (EBER) by in situ hybridization (ISH) (previous test results may be used as evidence if available)
. Part 1: Histologically or cytologically confirmed lymphoma or solid tumor
. Part 2: Histologically or cytologically confirmed solid tumor
. Part 3: Patients who have been diagnosed with histologically confirmed extranodal NK/T-cell lymphoma (ENKL) according to WHO classification
. Parts 4 and 5: Patients with histologically confirmed gastric cancer or esophageal adenocarcinoma
. Patients who have given written consent to voluntarily participate in the epitope screening
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Confirmed objective response rate (confirmed ORR) [assessed by IRRC]
. Patients with hemophagocytic lymphohistiocytosis (HLH)
. Persons who have previously received a solid organ transplant
. Persons who have been diagnosed with a malignant tumor other than the target disease in the past 5 years (treated basal cell carcinoma, squamous epithelial cell carcinoma, and non-invasive cervical cancer do not necessitate exclusion)
. Patients in whom a tuberculosis infection was confirmed in the 1 year prior to screening for the present study (However, patients who have been determined to be cured after treatment may be enrolled.)
. Patients who test positive for anti-HIV antibodies
. Patients deemed unsuitable to participate in the clinical trial by an investigator based on active infection (HBV, HCV) test results
. Persons who have been found to be capable of production in the epitope screening test